Clinical Trials Logo

Filter by:
NCT ID: NCT01387269 Completed - Clinical trials for Non-Small Cell Lung Cancer

Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)

Start date: July 2011
Phase: Phase 3
Study type: Interventional

The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

NCT ID: NCT01379703 Completed - HIV-1 Patients Clinical Trials

Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use

KaleEAST
Start date: February 2004
Phase: N/A
Study type: Observational

KaleEAST is a non-interventional, post-marketing observational study (PMOS) in which lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No additional procedures (other than the standard of care) are to be applied to the patients. The KaleEAST PMOS was conducted in a prospective, single-arm, multicountry, multicenter format. The study was carried out in two (2) parts: the first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation, the second part started in 2006 after the lopinavir/ritonavir tablets had become available in the participating countries. The aim of this post-marketing observational study was to obtain further data on clinical, biological, and virological outcomes, compliance and tolerability of Kaletra®-containing regimen during routine clinical use in the participating countries.

NCT ID: NCT01377922 Completed - Clinical trials for Lambert Eaton Myasthenic Syndrome

A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)

Start date: June 2011
Phase: Phase 3
Study type: Interventional

A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).

NCT ID: NCT01376700 Terminated - Hemophilia A Clinical Trials

Early Prophylaxis Immunologic Challenge (EPIC) Study

EPIC
Start date: August 26, 2011
Phase: Phase 3
Study type: Interventional

The purpose of the study was to assess if a once-weekly prophylactic regimen of 25 IU/kg ADVATE started at or before 1 year of age and before the onset of a severe bleeding phenotype (ie, joint bleeding), together with the minimization of immunological danger signals, can reduce the incidence rate of inhibitor formation in PUPs with severe and moderately severe hemophilia A.

NCT ID: NCT01376297 Completed - Clinical trials for Chemotherapy-Induced Nausea and Vomiting

A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

Start date: July 2011
Phase: Phase 3
Study type: Interventional

NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs, both given with oral dexamethasone. The objective of the study is to evaluate if netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.

NCT ID: NCT01371747 Completed - Hypertension Clinical Trials

Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN)

AMETHYST-DN
Start date: June 2011
Phase: Phase 2
Study type: Interventional

This study determined the optimal starting dose of patiromer in treating hyperkalemia in participants with hypertension and diabetic nephropathy who were already receiving ACEI and/or ARB drugs, with or without spironolactone. This study also evaluated the efficacy and safety of patiromer and the long term use of patiromer.

NCT ID: NCT01371357 Completed - Clinical trials for Hyperhomocysteinemia

The Effects of 8-week Choline, Betaine, and Folic Acid Supplementation on Plasma Homocysteine Concentration During Guanidinoacetic Acid Loading in Young Healthy Volunteers

Start date: May 2011
Phase: Phase 3
Study type: Interventional

A methyl-group acceptor such as guanidinoacetic acid (GAA) could induce hyperhomocysteinemia with the effects of GAA expected to be dose-dependent. Due to the fact that hyperhomocysteinemia is thought to be an independent risk factor for cardiovascular and neurodegenerative diseases, different dietary agents were used in the past for the treatment of elevated total plasma homocysteine (T-HCy), e. g. betaine, choline (betaine precursor) or folic acid. In the context of GAA loading the question arises whether intake of betaine, choline (betaine precursor) or folic acid during GAA loading could affect plasma T-HCy in healthy humans. Forty healthy physically active men and women aged 20 to 30 years will take part in this GAA-controlled, double-blind and parallel-group intervention study. Subjects will be allocated to four randomly assigned trials, with treatment lasting for 8 weeks and washout period of 28 days. The 4 test treatment-groups will include TEST1 (GAA only), TEST2 (GAA, choline, B6, B12 and folic acid), TEST3 (GAA, betaine, B6, B12 and folic acid) and TEST4 (GAA, B6, B12 and folic acid). Plasma T-HCy will be the primary outcome measure assessed every second week throughout the study. Plasma B-vitamins and blood and urine metabolites (GAA, creatine, methionine, arginine) will be secondary outcome measures along with adverse-effects indicators assessed every second week throughout the study. Selected body composition indicators will be obtained at 0, 2, 8 and 12 weeks throughout the study to monitor the effects of experimental treatments on body hydration and protein synthesis. This research will test the hypothesis that a combination of GAA with homocysteine lowering nutrients attenuates the elevation of T-hcy, and will further display the size-effect of each additive used.

NCT ID: NCT01369355 Completed - Crohn's Disease Clinical Trials

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)

Start date: September 13, 2011
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.

NCT ID: NCT01369342 Completed - Crohn's Disease Clinical Trials

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

Start date: July 2011
Phase: Phase 3
Study type: Interventional

This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.

NCT ID: NCT01369329 Completed - Crohn's Disease Clinical Trials

A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)

Start date: July 2011
Phase: Phase 3
Study type: Interventional

This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab pegol).